A clinical study to assess the efficacy of a green-lipped mussel (GLM) extract in people with knee osteoarthritis.

A phase IIa double-blind, randomised, placebo-controlled study investigating the efficacy and safety of GlycOmega PLUS supplementation in the treatment of osteoarthritis of the knee.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000261718

Enrollment

110

Registered

2013-03-05

Start date

2013-02-28

Completion date

2014-01-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We have clinically investigated GlycOmega Plus in two previous clinical trials (with no placebo arm) in participants with knee OA. Both trials demonstrated significant improvement in knee pain, stiffness and physical function at a dose of 3000mg per day for 8-12 weeks. This current trial aims to determine the clinical effectiveness of GlycOmega Plus in treating OA knee pain, stiffness and physical function at a dose of 1500mg for 12 weeks in a randomised placebo controlled design. Further we aim to assess faecal bacterial profiles to determine if participants with OA demonstrate altered bacterial growth and whether influencing bacterial growth with the supplementaion of GlycOmega Plus can be correlated to improve knee OA symptoms.

Interventions

The active treatment group will recieve green-lipped mussel extract capsules (500mg x 3 per day) to be taken orally each morning with breakfast for 12 weeks duration. The capsules will contain whole green-lipped mussel meat that has been freeze dried and converted to a powder for encapsulation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

Age 40 years and older with clinical evidence of painful knee (osteoarthritis) OA for at least 6 months (with a pain numerical scale of 4 and above at baseline) and radiographic evidence of knee OA as determined as having a kellgren-Lawrence grade 2- or 3-. Not taking any dietary supplements including fish oils, glucosamine, green-lipped mussel, herbal preparations, antibiotics and probiotics 4 weeks before commencing trial.

Exclusion criteria

knee replacements(s) of affected knee with OA; intra-articular therapies (knee cortisone injection and arthroscopy) within 3 months of starting the trial; pregnancy; use of illicit drugs; alcohol abuse; shell fish allergy; uncontrolled chronic health conditions i.e. diabetes, hypertension, cardiovascular disease; the inability to with-hold from using non-steroidal antiinflammatory drugs (NSAIDs) for the duration of the trial

Outcome results